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A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

This study has been completed.

Sponsors and Collaborators: Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00500370
  Purpose

This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.


Condition Intervention Phase
Obesity
Drug: exenatide
Drug: placebo
Phase II

MedlinePlus related topics:   Obesity    Weight Control   

Drug Information available for:   Exenatide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • To compare change in body weight in non-diabetic, obese patients with and without impaired glucose tolerance and/or impaired fasting glucose with twice daily exenatide plus lifestyle modification plan or placebo plus lifestyle modification plan [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the placebo and exenatide treatment groups on the change in: *Body Mass Index (BMI) *Waist circumference and hip circumference *Proportion of patients experiencing >=5% weight loss *Various pharmacodynamic measurements [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • *Beta cell function and insulin sensitivity *Proportion of patients that demonstrate overt signs of diabetes diagnosis or normalization of impaired fasting glucose and/or impaired glucose tolerance *Safety and tolerability *Health outcome measures [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   160
Study Start Date:   June 2007
Study Completion Date:   February 2008
Primary Completion Date:   February 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Group A: Experimental Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Group B: Placebo Comparator Drug: placebo
subcutaneous injection (equivalent volume to active dose), twice a day

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Have a Body Mass Index (BMI) >= 30kg/m^2

Exclusion Criteria:

  • Have ever participated in this study previously, or any other study using exenatide (AC2993/LY2148568) or GLP-1 analogs
  • Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry)
  • Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for > 3 months
  • Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening
  • Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
  • Are actively participating in, or have participated in a formal weight loss program within the last 3 months
  • Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics
  • Have been treated with any anti-diabetic medications within 3 months of screening
  • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start
  • Have had bariatric surgery
  • Have had an organ transplant
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500370

Locations
United States, Arizona
Research Site    
      Tucson, Arizona, United States
Research Site    
      Peoria, Arizona, United States
United States, California
Research Site    
      Santa Ana, California, United States
United States, Indiana
Research Site    
      Indianapolis, Indiana, United States
United States, Kansas
Research Site    
      Topeka, Kansas, United States
Research Site    
      Wichita, Kansas, United States
United States, Louisiana
Research Site    
      Baton Rouge, Louisiana, United States
United States, Missouri
Research Site    
      St. Louis, Missouri, United States
United States, Oklahoma
Research Site    
      Oklahoma City, Oklahoma, United States
United States, South Carolina
Research Site    
      Goose Creek, South Carolina, United States
Research Site    
      Spartanburg, South Carolina, United States
United States, Texas
Research Site    
      Dallas, Texas, United States
Research Site    
      San Antonio, Texas, United States
United States, Washington
Research Site    
      Renton, Washington, United States
Puerto Rico
Research Site    
      San Juan, Puerto Rico
Research Site    
      Ponce, Puerto Rico

Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
Eli Lilly and Company

Investigators
Study Director:     James Malone, MD     Eli Lilly and Company    
  More Information


Responsible Party:   Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers:   H8O-MC-GWBP
First Received:   July 10, 2007
Last Updated:   March 3, 2008
ClinicalTrials.gov Identifier:   NCT00500370
Health Authority:   United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:
exenatide  
obesity  
diabetes  
Amylin  
Lilly  

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Exenatide
Diabetes Mellitus
Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 04, 2008




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